60 results

• Medtronic Dialysis Catheter Recall Issued Over Risk of Leaks

  July 12, 2022

  Russell Maas

  Medtronic is recalling more than a million dialysis catheters due to a risk of leaking which could lead to blood clots, strokes and heart attacks.

• Abbott Dragonfly OpStar Catheter Recall Issued Over Tip Separation Risks

  May 31, 2022

  Russell Maas

  A Dragonfly OpStar Imaging Catheter recall was announced after reports of tip separations.

• Medtronic Harmony Delivery Catheter Recall Issued Following Reports of Capsule Breaking

  April 27, 2022

  Russell Maas

  Medtronic is recalling hundreds of Harmony Delivery Catheters due to a risk of separated tips, patient injuries and deaths.

• Medtronic TurboHawk Catheter Recall Issued Due to Tips Breaking

  March 10, 2022

  Randy Dixon, Jr.

  The FDA has given a class I designation to a recall of Medtronic TurboHawk atherectomy systems due to a risk of the catheter tips breaking off and causing life-threatening arterial injuries.

• Medtronic HawkOne Directional Atherectomy System Recall Issued Over Broken Tip Risks

  January 25, 2022

  Irvin Jackson

  Medtronic is recalling more than 95,000 HawkOne Directional Atherectomy Systems whose catheter tips could break off, putting patients' lives at risk.

• Cook Medical Transseptal Needle Recall Issued Over Rust, Which Could Be Fatal

  October 20, 2021

  Martha Garcia

  Cook Medical has issued a global recall for its Transseptal Needles with and without catheters following four reports of rust being detected on devices which were used on patients.

• Kodama Catheter Recall Issued Due To Risk Broken Pieces May Flush Into Patient Arteries

  March 18, 2021

  Russell Maas

  The FDA has determined a problem with Kodama ultrasound catheters could put patients at risk of death, resulting in a nationwide recall.

• Penumbra Catheter Recall Over JET 7 Xtra Flex Tip Damage Categorized as Class I by FDA

  February 1, 2021

  Irvin Jackson

  The FDA has issued a Class I classification to a Penumbra Jet 7 Xtra Flex Catheter recall, following reports of deaths and severe patient injuries.

• Deadline Established For Lead Plaintiff in Class Action Lawsuit Over Penumbra Jet 7 Xtra Flex Catheter

  January 28, 2021

  Irvin Jackson

  Investors seeking to participate in a recently filed Penumbra Jet 7 Xtra Flex catheter class action lawsuit have until March 16 to file a complaint if they want to be a lead plaintiff in the litigation.

• Penumbra Catheter Problems Results in Class Action Lawsuit After Jet 7 Xtra Flex Recall

  January 19, 2021

  Irvin Jackson

  A class action lawsuit accuses of Penumbra of misleading investors by not telling them of problems with its Jet 7 Xtra Flex catheters, which eventually led to a recall and a significant drop in the company's stock market value.