Recalls / —
—#188468
Product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
- FDA product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K133843
- Affected lot / code info
- Lot/Batch number 82219442
Why it was recalled
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices.
Recalling firm
- Firm
- Cordis Corporation
- Address
- 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Timeline
- Recall initiated
- 2021-07-19
- Terminated
- 2023-02-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #188468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.