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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis SABER PTA Balloon Dilation Catheter

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 Class 2 Device Recall Cordis SABER PTA Balloon Dilation Cathetersee related information
Date Initiated by FirmJuly 19, 2021
Create DateAugust 09, 2021
Recall Status1 Terminated 3 on February 16, 2023
Recall NumberZ-2235-2021
Recall Event ID 88348
510(K)NumberK133843 
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
ProductCordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Code Information Lot/Batch number 82219442
FEI Number 1016427
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact
786-313-2000
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices.
Quantity in Commerce8 units
DistributionWorldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LIT
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