The Missing Times

The Missing Times

The World's Daily Newspaper of What the Fronts Left Thin

Devices · FDA · Impella

Every Impella controller is being pulled after three deaths. Hospitals will keep using them.

CDRH Early Alert. Abiomed’s Aug. 12 letter recommends that all Automated Impella Controllers be removed from where they are used or sold. As of Aug. 17: 37 serious injuries and three deaths. Hospital inventory may continue while replacements are phased in.

Archive: cardiac catheterization lab, Naval Medical Center San Diego, 29 Sept 2020. Not an Impella catheter, Automated Impella Controller, Abiomed device, or a patient on Impella support.
Archive: cardiac catheterization lab, Naval Medical Center San Diego, 29 Sept 2020 (Jake Greenberg, U.S. Navy, public domain). Not an Impella catheter, Automated Impella Controller, Abiomed device, or a patient on Impella support.

New York — The consoles are coming out. The pumps stay in. The Food and Drug Administration’s Center for Devices and Radiological Health issued an Early Alert that Abiomed has told customers to take every Automated Impella Controller out of the places where the devices are used or sold. The U.S. product codes on the FDA page are 0042-0000-US, 0042-0010-US and 0042-0040-US; each line carries a unique device identifier in the same table. The Automated Impella Controller is the primary user control interface for the Impella Catheter. It runs catheter performance, watches alarms and shows the catheter’s position across the aortic valve.

Abiomed is removing the controllers because of purge-cassette recognition failures from a failing “purge flag” in the purge pressure sensor assembly. The flag engages the purge disc so the controller can tell the disc is seated. If the flag fails during setup, the FDA said, the screen shows a “Purge Disc Disconnected” alarm. During hemodynamic support the alarm is “Purge Disc not Detected.” In either case the instructions for use say to reinsert the purge disc; if the alarm does not clear, switch to a backup Automated Impella Controller. Failures during support usually happen in an elective purge-cassette exchange, the FDA said, but can happen while support is already running. Mechanical circulatory support continues while purge delivery stops and an exchange is planned.

If the failure happens before support starts, there may be a delay to the procedure. In hemodynamic instability, that delay can mean a prolonged period without mechanical circulatory support. As of Aug. 17, Abiomed had reported 37 serious injuries and three deaths associated with this issue. The customer letter went out Aug. 12. All AIC units globally are in the removal. Hospital inventory may continue to be used while awaiting replacement, the FDA said, “to ensure continuity of care.” The work is phased: annual preventive maintenance or outreach by Abiomed’s field-service team, which will replace the purge flag and the purge retainer in the purge pressure sensor assembly. The FDA page lists an Abiomed telephone line, (978) 646-1400, and a field-action address at OneMD-Field-Actions@its.jnj.com, a Johnson & Johnson MedTech email as printed on the alert.

AHA News, in an Aug. 27 headline, carried the same three deaths and 37 serious injuries and identified the maker as Abiomed. We did not open a prior-recall history. We did not invent one.

US hook — three deaths and 37 serious injuries on a last-resort heart-pump console still sitting in U.S. hospitals while a global removal crawls through annual maintenance. Wire gap — Sunday homepages we opened at the New York Times, AP, NBC News, CBS News, CNN (U.S. and main) and ABC News led with Nepal-Tibet floods (600–700 dead, about 3,000 missing), Venezuela oil-deal follow-ups, Milo Yiannopoulos’s deportation, the Iran war at six months, Kevin Warsh and the Fed, the Lindsay Clancy trial, Lake America/Ontario color, an El-Sayed synagogue apology, a Ukrainian warehouse strike that killed 37, and leftover Dolly/airport-rename. CNN’s U.S. page still carried Friday’s Longview tank leftover; we are not reprinting it. The Impella Early Alert lived on fda.gov and on AHA News on Aug. 27. It was not on those opened homepages. The Washington Post timed out. Reuters’s homepage returned 401; we opened only the /world/us/ and /world/ sections.

Sources: - https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-heart-pump-controller-purge-cassette-issue-abiomed - https://www.aha.org/news/headline/2026-08-27-fda-issues-early-alert-heart-pump-controllers-following-3-deaths-dozens-injuries

Opioids · DOJ · retail pharmacy

Walmart pays $50 million to end the federal opioid pharmacy case. It called the sum immaterial.

Justice Department and DEA, Friday. $50 million to resolve allegations that Walmart pharmacies filled thousands of invalid opioid and other controlled-substance prescriptions. A Walmart filing, as reported by Al Jazeera, called the amount “immaterial.”

Archive: pharmacist labeling a prescription, National Naval Medical Center Bethesda, 19 Aug 2003. Not a Walmart pharmacy, pharmacist, or trademark.
Archive: pharmacist labeling a prescription, National Naval Medical Center Bethesda, 19 Aug 2003 (Seth Rossman, U.S. Navy, public domain). Not a Walmart pharmacy, pharmacist, or trademark.

New York — Walmart Inc. will pay $50 million. The Justice Department, with the Drug Enforcement Administration, announced the settlement Friday to resolve allegations that Walmart pharmacies illegally filled thousands of invalid prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act. Press release number 26-996. Associate Attorney General Stanley Woodward said the department would “never shy away from vigorously enforcing pharmacies’ obligations” and that “potential profits never justify aiding our Nation’s opioid epidemic.” DEA Assistant Administrator Cheri Oz, in a quote the department added to the updated release, said filling illegitimate opioid prescriptions “puts patients and communities at risk” and that the settlement “establishes clear compliance obligations.”

The government’s complaint — filed Dec. 22, 2020, and amended in 2022 in the U.S. District Court for the District of Delaware — alleged that since June 26, 2013, Walmart filled invalid prescriptions through the knowing actions of its compliance team and its pharmacists. Compliance staff, the United States alleged, knew certain prescribers were operating as “pill mills” because Walmart’s own pharmacists reported them, including through thousands of “refusal-to-fill” forms. The compliance team “prioritized other goals over CSA compliance.” As one director on that team acknowledged in an email, rather than analyzing those reports, the team viewed “[d]riving sales and patient awareness” as “a far better use of our Market Directors and Market manger’s time.” Pharmacists also allegedly filled scripts they knew were invalid: written by a known pill-mill prescriber, or carrying obvious red flags — dangerous combinations of opioids, “cocktails” of opioids and non-opioids, excessively repeated high-dose fills of often-abused opioids, or repeated early fills. Walmart signed a DEA memorandum of agreement requiring a tip hotline for employees and patients, proactive monitoring of pharmacy dispensing, and a process to evaluate suspect prescribers. The claims resolved by the settlement are allegations only; there has been no determination of liability.

Al Jazeera, writing Friday, reported that a Walmart regulatory filing called the settlement amount “immaterial.” Net income, Al Jazeera wrote, was $11.7 billion in the six months ending July 31. At the time of the complaint, Al Jazeera wrote, the Justice Department said Walmart could face billions of dollars in civil penalties. In 2022, Al Jazeera wrote, Walmart paid $3.1 billion to settle thousands of state and local opioid lawsuits. Walmart’s statement, as Al Jazeera quoted it: “We are pleased to resolve this matter and will continue supporting the exceptional work our pharmacists do every day to provide outstanding patient care.” Al Jazeera, citing the CDC, wrote that more than 905,000 people in the United States died from opioid overdoses between 1999 and 2025. In March 2024, Al Jazeera wrote, U.S. District Judge Colm Connolly narrowed the federal case, dismissing some claims and leaving the government to pursue the allegation that pharmacists dispensed prescriptions Walmart compliance personnel knew were invalid. The $50 million figure is the Justice Department’s. We did not take Al Jazeera’s line that the terms were undisclosed.

US hook — the country’s largest retailer closes the 2020 federal CSA case for a sum it labeled immaterial, against an overdose-death count Al Jazeera put, via the CDC, above 905,000. Wire gap — Reuters’s /world/us/ section listed “Walmart settles US government’s opioid lawsuit for $50 million”; that is a section list, not a homepage lead. Sunday homepages we opened at the New York Times, AP, NBC News, CBS News, CNN and ABC News did not lead with it. They were on Nepal floods, Venezuela oil, Milo’s deportation, Iran at six months, Warsh and the Fed, Clancy, and Lake America color. The settlement lived on justice.gov Friday and in Al Jazeera’s economy file. The Washington Post timed out. Reuters’s homepage returned 401.

Sources: - https://www.justice.gov/opa/pr/walmart-agrees-pay-50-million-illegally-filling-unlawful-opioid-prescriptions - https://www.aljazeera.com/economy/2026/8/28/walmart-settles-us-governments-opioid-lawsuit

Child welfare · Idaho · faith healing

Fifteen Idaho children died of treatable illnesses. The faith-healing shield still stands.

ProPublica and The Oregonian, in a late-August investigation, found at least 15 Followers of Christ babies and children dead from 2015 to 2025 of illnesses doctors said they could have treated. Idaho’s 1970s exemption still bars prosecution for refusing care.

Archive: Main Street, Caldwell Historic District, Idaho, 10 June 2018. Not Peaceful Valley Cemetery, children’s graves, or a Followers of Christ church.
Archive: Main Street, Caldwell Historic District, Idaho, 10 June 2018 (Tamanoeconomico, CC BY-SA 4.0). Not Peaceful Valley Cemetery, children’s graves, or a Followers of Christ church.

New York — At least 15 babies and children in the Followers of Christ sect died between 2015 and 2025 from illnesses doctors could have treated. That is ProPublica’s count, in a late-August investigation with The Oregonian/OregonLive, after experts reviewed coroner and police records from five Idaho counties. More than a dozen pediatricians and birthing specialists read the files. Six more deaths could not be evaluated because records were incomplete or unavailable. Four were inconclusive. At least five sets of parents lost more than one child.

One of those households lost two newborns 13 months apart. Malachi died in October 2023 of pneumonia and bleeding lungs. Doctors who reviewed his records for ProPublica said antibiotics and hospital newborn care would have treated it. The next newborn, Liam, died of the same treatable pneumonia. ProPublica did not name the parents. We are not naming them. Canyon County Sheriff Kieran Donahue, who has sent deputies on at least 10 Followers children’s deaths since he took office in 2013, told ProPublica: “This is needless.” “This shouldn’t be happening.” David Peterman, a retired Idaho pediatrician who reviewed 18 infant and child deaths for ProPublica, said the vast majority “are the result of neglect and unequivocally preventable.” “How is this tolerable?”

Idaho’s criminal and civil laws have, since the 1970s, exempted faith-healing parents from medical-neglect prosecution and from foster-care removal solely for refusing care. Oregon repealed its exception nearly 30 years ago; more parents sought care after the change, Oregon prosecutors and detectives told ProPublica. Idaho lawmakers have rejected efforts to roll back the exemption since 2014. Instead they have expanded “parental rights,” banned vaccine requirements in schools and childcare, and made parental consent a prerequisite for medical care of minors. Nathan Kangas, a patriarch of the Caldwell church, defended faith healing to ProPublica. He quoted Psalms — “Precious in the eyes of the Lord are the death of His saints” — and the Book of James on affliction and mourning. “It isn’t necessarily that we’re supposed to have a joyous life here,” he said. “It’s actually quite the opposite.”

The deaths were not sudden unknowns. Maicy, 16, died on New Year’s Day 2019 from a treatable pituitary tumor after years of stunted growth; she was 62 pounds and just shy of 4 feet. Dallas, 2, was sick for six weeks in 2020 with an untreated bacterial infection that destroyed a heart valve; doctors who reviewed the autopsy for ProPublica said antibiotics at any point in those six weeks could have saved him. Brothers Camden and Weston died of sepsis from common infections in 2024 and 2025. Members of the sect bury their dead at Peaceful Valley Cemetery in Caldwell.

US hook — a U.S. state statute still shielding parents after a decade of preventable child deaths, documented in coroner files. Wire gap — Sunday homepages we opened at the New York Times, AP, NBC News, CBS News, CNN and ABC News were on Nepal-Tibet floods, Venezuela oil, Milo Yiannopoulos’s deportation, the Iran war at six months, Warsh and the Fed, the Clancy trial, and Lake America color. The investigation lived on propublica.org, with The Oregonian. It was not on those opened homepages. The Washington Post timed out. Reuters’s homepage returned 401.

Sources: - https://www.propublica.org/article/faith-healing-idaho-deaths-followers-of-christ

Today In History

Five years ago the last American planes left Kabul.

On this date in 2021, the United States completed its withdrawal from Afghanistan, ending America's longest war with the Taliban back in power. Air Force transports lifted the remaining troops from Kabul airport. After the last aircraft disappeared, Taliban fighters fired into the air.

The same square on the calendar holds an older American first. In 1967 the Senate confirmed Thurgood Marshall as the first Black justice of the U.S. Supreme Court.

Also on this date

  • 1922 The Battle of Dumlupınar, the final battle of the Greco-Turkish War.
  • 1916 On his fourth attempt, Ernest Shackleton reaches Elephant Island and rescues 22 of his men, stranded four and a half months after the Endurance sank.
  • 1963 The Hot Line between Washington and Moscow goes into operation.
  • 1945 Gen. Douglas MacArthur arrives in Japan to set up Allied occupation headquarters.
  • 1941 German forces cut the remaining rail line out of Leningrad.
  • 2005 A day after Hurricane Katrina, floodwater covers 80 percent of New Orleans. Rescuers in helicopters and boats pick up hundreds of stranded people.

Born this day: Mary Shelley, 1797. Queen Anne-Marie of Greece, 1946.

Died this day: Mikhail Gorbachev, 2022, at 91. Seamus Heaney, 2013.