The FDA warned Zimmer Biomet (NYSE:ZBH) in May about a series of quality system violations the federal safety watchdog flagged during January inspections of a plant in Montreal. The plant makes the iAssist and Zimmer PSI knee systems, the Zimmer PSI shoulder and the Navitrack software system, according to a warning letter dated May 27 and released June 30. […]
Warning Letter
FDA warns Medtronic’s Tyrx on anti-bacterial envelopes
The FDA sent a warning letter earlier this month to Medtronic (NYSE:MDT) subsidiary Tyrx over problems with its process validation and quality systems. The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac […]
FDA warns Spectranetics on Glidelight, SLS II lead extraction sheaths
The FDA sent a warning letter last month to Spectranetics (NSDQ:SPNC), flagging the company for problems with its GlideLight and SLS II lead extraction sheaths made in Colorado. The FDA inspected Spectranetics’ Colorado Springs facility from the end of November 2015 through January 21, issuing a Form 483 warning based on problems found during the inspection. […]
FDA: US medical device inspections down in 2015
The FDA said this week that it inspected fewer U.S. medical device plants last year than in 2014, but sent inspectors to more overseas facilities. The overall number of quality systems inspections fell -5% to 2,104 during calendar 2015, the federal safety watchdog said, but U.S. inspections were down -5% to 1,484 while foreign inspections rose […]
FDA lifts final warning letters for AngioDynamics
AngioDynamics (NSDQ:ANGO) said today that the FDA closed out a pair of warning letters sent in 2011 and 2014, closing the book on all warning letters sent to the Latham, N.Y.-based medical device company. The federal safety watchdog last month resolved another warning letter sent to AngioDynamics in January 2011 over the NanoKnife tissue ablation device. AngioDynamics said the FDA […]
FDA slams Sironis for running unapproved trial
The FDA slammed Sironis for running an unapproved clinical trial of its LIR closed-loop fluid administration system, saying the Newport Beach, Calif.-based company never sought the proper approvals from the federal safety bureau. In a warning letter dated March 15 and released by the FDA this week, the agency flagged Sironis for serious violations of […]
FDA warns endoscope makers on superbug infections
The FDA today published warning letters it sent earlier this month to the 3 largest makers of endoscopes on the U.S. market, cautioning the companies about violations found during spring inspections at plants in the U.S. and Japan. The inspections followed a string of deadly “superbug” infections attributed to duodenoscopes made by Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya‘s (TYO:7741) Pentax […]
Alphatec reveals FDA warning letter
Alphatec (NSDQ:ATEC) yesterday revealed that it received a warning letter from the FDA over problems at a plant in its home base of Carlsbad, Calif. The July 16 warning letter cites 8 “deficiencies” in Alphatec’s response to the FDA’s initial observations after it inspected the plant in February and March, the company said. “The deficiencies relate […]
Bard reveals FDA warning letter over IVC filter retrievers
C.R. Bard (NYSE:BCR) today revealed that it received a warning letter from the FDA over problems found at a pair of plants that make devices to retrieve inferior vena cava filters. The July 12 warning letter from the FDA’s Los Angeles office “specifically cites quality systems and medical device reporting observations relating to non-conformances” found during […]
SynCardia warns on artificial heart driver
SynCardia Systems sent a letter to surgeons yesterday warning them about issues with a component of its artificial heart in patients who received pre-implant circulatory rescue interventions. The letter concerns Syncardia’s Total Artificial Heart Companion 2 Driver system. SynCardia won FDA approval for the C2 system in 2012 as a smaller replacement for the CSS console, which won […]
FDA warns Insulet on Eros OminPod
(Reuters) — Insulet (NSDQ:PODD) said yesterday that it received a warning letter from the FDA over some of its insulin pumps. Insulet said the letter, which it received June 8, followed an FDA inspection of its facility in Billerica, Mass., in March. That inspection resulted in a Form 483, usually issued at the end of an […]