CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
Pas-port Proximal Anastomosis Device Us recalled
Aesculap Implant Systems is recalling Pas-port Proximal Anastomosis Device Us, distributed nationwide in the US. The recall was initiated on 16 Apr 2021 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-2579-2021
- FDA event ID
- 88327
- Recalling firm
- Aesculap Implant Systems, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2021
- FDA classified
- 27 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Apr 2021 | Recall initiated by company | |
| 27 Sep 2021 | Classified by FDA | +164 days |
| 6 Oct 2021 | 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
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Product as listed by the FDA
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Where it was distributed
US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Questions about this recall
Why was it recalled?
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Which lots are affected?
All batch codes
Where was it sold?
US Nationwide distribution in the states of FL, MI, NY, TX, WI.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88327This product is part of a recall event; the main page for the event is Pas-port Proximal Anastomosis System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pas-port Proximal Anastomosis System recalled | Aesculap Implant Systems | Other | Nationwide |
More recalls from Aesculap Implant Systems
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | For intraventricular recalled by Aesculap Implant Systems | Aesculap Implant Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Aesculap Surgical Needle, straight, 3 1/2", width recalled | Aesculap Implant Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems | Aesculap Implant Systems | Other | Nationwide |
| Device | CLASS II | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled | Aesculap Implant Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Aesculap Ennovate Set Screw Sterile-implants are used recalled | Aesculap Implant Systems | Packaging Defects | GA, TX |
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