Cordis Corporation recalls
Every recall we track for Cordis Corporation — 19 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Cordis Corporation peaked in 2021 (14); 19 since 2017. 5% rated “stop using now”.
All FDA recall records for Cordis Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 0 | 0 | 1 |
| 2018 | 1 | 0 | 0 | 0 | 1 |
| 2019 | 0 | 1 | 1 | 0 | 2 |
| 2020 | 0 | 0 | 0 | 1 | 1 |
| 2021 | 0 | 6 | 8 | 0 | 14 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Cordis Corporation recalls
What to do if you have a recalled Cordis Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Cordis Corporation recalls
10 shown- Use cautionMedical device
Cordis Corporation recalls SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of
Cordis recalls SMART Flex 6x150 BIL, 120cm biliary stent systems with potential for distal tip dislodgement. Affected units have specific product codes and lot numbers.
CordisOct 1, 2021 - Lower riskMedical device
Cordis Corporation recalls Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Cordis recalls 5F Universal Flush F4 Super Torque MB Angiographic Catheters (REF SRD6785MB) due to potential entrapment between devices and vessel walls, risking marker band dislodgement.
CordisJul 21, 2021 - Lower riskMedical device
Cordis Corporation recalls Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Cordis recalls SABER PTA Balloon Dilation Catheter (4F, REF 48004010X) due to potential contamination in the balloon sheath that could transfer foreign material to the balloon.
CordisJul 19, 2021 - Lower riskMedical device
Cordis Corporation recalls Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring
Cordis recalls Avanti+ Catheter Sheath Introducer due to being larger than labeled dimensions, which may cause improper use in medical procedures.
CordisJun 9, 2021 - Lower riskMedical device
Cordis Corporation recalls PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC,
Cordis recalls specific lots of PRECISE PRO RX carotid stent implants due to risk of distal tip separation from lumen wire. Affected product codes and lot numbers listed.
CordisFeb 11, 2021 - UnratedMedical device
Cordis Corporation recalls Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Cordis recalls one lot of POWERFLEX P3 PTA Dilation Catheter (REF 420-6020S) due to potential body shaft voids in the proximal seal area. Affected units have lot number 82155955 with use by date 2021-06-30.
CordisJan 8, 2020 - Use cautionMedical device
Cordis Corporation recalls Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Cordis recalls MAXI LD PTA Dilatation Catheters made with expired inner body. This could cause device failure during cardiovascular procedures. Affected units have specific catalog and lot numbers.
CordisOct 4, 2019 - Lower riskMedical device
Cordis Corporation recalls Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for
Cordis recalls specific lots of Vista Brite Tip & Androit Guiding Catheters due to frayed mounting card pieces in primary packaging. No remedy is stated in the recall notice.
CordisFeb 7, 2019 - Stop using nowMedical device
Cordis Corporation recalls Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral,
Cordis recalls POWERFLEX PRO PTA Dilatation Catheters due to potential burst shaft failure during use. Affected units have specific catalog and lot numbers. Stop using immediately if you own one.
CordisSep 5, 2018 - Use cautionMedical device
Cordis Corporation recalls Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant
Cordis recalls S.M.A.R.T. Flex Biliary Stent Systems with potential cracked luer hubs that could cause leaks or dislodgement during medical procedures.
CordisNov 15, 2017
Cordis Corporation recall questions
How many recalls has Cordis Corporation had?
19 recalls from Cordis Corporation are on record with U.S. safety agencies, from 2017–2021.
What is the most recent Cordis Corporation recall?
Cordis Corporation recalls SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of, dated Oct 1, 2021. Every Cordis Corporation recall is listed on this page, newest first.
Why are Cordis Corporation products recalled?
The most common reasons on record: There is a potential for distal tip dislodgement or separation. (6).
What should I do if I have a recalled Cordis Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Cordis Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.