FDA Device recall Z-0991-2014
MORPH ACCESSPRO Steerable Introducer
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of MORPH ACCESSPRO Steerable Introducer by Biocardia, citing tyvek packaging may be worn, causing loss of package integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0991-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-07 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biocardia |
| Distribution | FL, KS, MA, MI, OH, WY |
Product
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
Reason
Tyvek packaging may be worn, causing loss of package integrity.
Identifiers
| code_info | Catalog number MAP690; Lot numbers 01162 and 01186. |
|---|
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-0991-2014%22
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