FDA Device recall Z-1528-2013
MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm)
- FDA Device
- Class II
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class II recall of MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm) by Bard Peripheral Vascular, citing bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1528-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-23 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath¿ is a single lumen catheter that has a 123cm working length and a straight tip shape
Reason
Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
Identifiers
| code_info | PC MS17123; Lot# FCWC10010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1528-2013%22
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