Amplatzer Steerable Delivery Sheath
Reported: April 13, 2022 Initiated: November 9, 2021 #Z-0895-2022
Product Description
Amplatzer Steerable Delivery Sheath
Reason for Recall
Instructions for use were updated.
Details
- Recalling Firm
- Abbott
- Units Affected
- 529 units
- Distribution
- OUS distribution only
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Amplatzer Steerable Delivery Sheath. Recalled by Abbott. Units affected: 529 units.
Why was this product recalled? ▼
Instructions for use were updated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0895-2022.
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