CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Saber PTA Balloon Dilation Catheter, 4F recalled by Cordis
Cordis is recalling Saber PTA Balloon Dilation Catheter, 4F, distributed nationwide in the US. The recall was initiated on 19 Jul 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-2235-2021
- FDA event ID
- 88348
- Recalling firm
- Cordis, Miami Lakes, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2021
- FDA classified
- 9 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 19 Jul 2021 | Recall initiated by company | |
| 9 Aug 2021 | Classified by FDA | +21 days |
| 18 Aug 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
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Questions about this recall
Why was it recalled?
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Which lots are affected?
Lot/Batch number 82219442
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
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.
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |