CLASS II Device recall · Reported 26 Feb 2014 · FDA Enforcement Report
Morph Accesspro Steerable Introducer recalled by Biocardia
Biocardia is recalling Morph Accesspro Steerable Introducer, distributed in Florida, Kansas, Massachusetts, Michigan, Wyoming. The recall was initiated on 7 Feb 2014 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-0991-2014
- FDA event ID
- 67492
- Recalling firm
- Biocardia, San Carlos, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2014
- FDA classified
- 19 Feb 2014
- Reported
- 26 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Feb 2014 | Recall initiated by company | |
| 19 Feb 2014 | Classified by FDA | +12 days |
| 26 Feb 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tyvek packaging may be worn, causing loss of package integrity.
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
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.
Where it was distributed
US Distribution including the states of FL, MA, WY. OH, MI and KS.
Questions about this recall
Is Morph Accesspro Steerable Introducer recalled?
Yes. Biocardia recalled Morph Accesspro Steerable Introducer on 7 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-0991-2014.
Why was it recalled?
Tyvek packaging may be worn, causing loss of package integrity.
Which lots are affected?
Catalog number MAP690; Lot numbers 01162 and 01186.
Where was it sold?
US Distribution including the states of FL, MA, WY. OH, MI and KS.
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 Biocardia
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Morph AccessPro Steerable Introducer recalled by Biocardia | Biocardia | Particulate Matter | Nationwide |
| Device | CLASS II | Morph AccessPro Steerable Introducer recalled by Biocardia | Biocardia | Particulate Matter | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |