CLASS II Device recall · Reported 19 Jun 2013 · FDA Enforcement Report
Microsheath¿ - 066 proximal recalled by Bard Peripheral Vascular
Bard Peripheral Vascular is recalling Microsheath¿ - 066 proximal, 064, distributed nationwide in the US. The recall was initiated on 23 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1528-2013
- FDA event ID
- 64276
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jan 2013
- FDA classified
- 10 Jun 2013
- Reported
- 19 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 23 Jan 2013 | Recall initiated by company | |
| 10 Jun 2013 | Classified by FDA | +138 days |
| 19 Jun 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Is Microsheath¿ - 066 proximal, 064 recalled?
Yes. Bard Peripheral Vascular recalled Microsheath¿ - 066 proximal, 064 on 23 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-1528-2013.
Why was it recalled?
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).
Which lots are affected?
PC MS17123; Lot# FCWC10010
Where was it sold?
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bard Peripheral Vascular
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|---|---|---|---|---|---|
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| Device | CLASS II | Venclose digiRF Generators recalled by Bard Peripheral Vascular | Bard Peripheral Vascular | Temperature Abuse | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |