Z-2235-2021Class II

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Name: Z-2235-2021 Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Creator: Cordis Corporation
Published: 2021-07-19
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2021-07-19 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X on 2021-07-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2235-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-19
Posted: 2021-08-09
Terminated: 2023-02-16
Recalling firm: Cordis US Corp.
Product: Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices.
Quantity in commerce: 8 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Product codes and lots: Lot/Batch number 82219442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2235-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2235-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-09

Product code LIT

K133843Class IISaber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation / cleared 2014-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)