June 18, 2019
FDA: Class I recall of Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter
Editor's Note
The Food & Drug Administration on June 18 identified the recall by Cook Incorporated (Bloomington, Indiana) of its Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6 mm x 4 cm as Class I, the most serious.
The recall was initiated because of multiple complaints of balloons bursting below the rated burst pressure. The catheter is used to open blocked or narrowed arteries that supply blood to the leg.
Distribution dates for the catheters are October 29, 2018, to March 21, 2019.
Free Daily News
- Milestone pig kidney transplant offers hope amid ethical, safety questions
- Fitch Ratings: Hospital credit outlook improves amid stabilizing margins
- Annual Leapfrog Group awards recognize top hospitals, ASCs
- US obesity rates decline for first time in a decade
- Study: Active monitoring without surgery safe for certain low-risk DCIS patients
- Data support option to skip sentinel lymph node biopsy in early breast cancer
- Surveyed nurses, physicians likely to quit
- Costs drop, access expands for GLP-1 weight loss drugs
- Q&A: Perioperative immunotherapy advances for early-stage NSCLC
- Proposals close December 16: Present at the 2025 OR Manager Conference
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement