Device product
The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths. The balloon has radiopaque markings to assist in balloon placement and to visualize proper expansion of the inflated balloon. The catheter tip is tapered to facilitate entry into peripheral arteries and across lesions. The catheter is designed to be used with appropriately sized guidewires and introducers.
Z-0507-2020
Product summary
- Event
- Event 84134
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49
- Official record key
device-enforcement:Z-0507-2020
Official wording
Reason: Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Code information: Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758
Distribution pattern: U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
Derived failure modes
-
Labeling or packaging
mislabeled