CLASS I Device recall · Reported 13 May 2020 · FDA Enforcement Report

Bard Embolectomy Catheter & Syringe recalled

Applied Medical Resources is recalling Bard Embolectomy Catheter & Syringe, distributed nationwide in the US. The recall was initiated on 24 Oct 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel CE0340DR, BARD CATHETER, lot numbers 1276248, 1283930, 1284935, 1286527, 1295731, 1317372, 1326198 Model CE0380DR, BARD CATHETER, lot numbers 1253338, 1260036, 1263505, 1268151, 1276218, 1283938, 1289018, 1299712, 1301797, 1308727, 1312145, 1314562, 1324334, 1335171 Model CE0440DR, BARD CATHETER, lot number 1286829 Model CE0480DR, BARD CATHETER, lot numbers 1263515, 1268153, 1276227, 1283943, 1284950, 1289021, 1293173, 1299711, 1301798, 1308737, 1312147, 1312986, 1318084, 1325785 Model CE0540DR, BARD CATHETER, lot numbers 1284054, 1284951, 1328361 Model CE0580DR, BARD CATHETER, lot numbers 1255414, 1263517, 1276230, 1283948, 1286831, 1289126, 1295732, 1301799, 1308735, 1317737, 1318091, 1325790, 1335172 Model CE0680DR, BARD CATHETER, lot numbers 1250869, 1260041, 1268157, 1276234, 1283950, 1284954, 1289024, 1295730, 1303736, 1308740, 1314577, 1318092, 1324358

Quantity recalled28,799 catheters in total

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-1847-2020
FDA event ID: 85057
Recalling firm: Applied Medical Resources, Rancho Santa Margarita, CA
Classification: Class I
Status: Terminated
Recall initiated: 24 Oct 2019
FDA classified: 7 May 2020
Reported: 13 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

24 Oct 2019	Recall initiated by company
7 May 2020	Classified by FDA	+196 days
13 May 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

Product as listed by the FDA

Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y

Where it was distributed

Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom

Nationwide

Questions about this recall

Why was it recalled?

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

Which lots are affected?

Model CE0340DR, BARD CATHETER, lot numbers 1276248, 1283930, 1284935, 1286527, 1295731, 1317372, 1326198 Model CE0380DR, BARD CATHETER, lot numbers 1253338, 1260036, 1263505, 1268151, 1276218, 1283938, 1289018, 1299712, 1301797, 1308727, 1312145, 1314562, 1324334, 1335171 Model CE0440DR, BARD CATHETER, lot number 1286829 Model CE0480DR, BARD CATHETER, lot numbers 1263515, 1268153, 1276227, 1283943, 1284950, 1289021, 1293173, 1299711, 1301798, 1308737, 1312147, 1312986, 1318084, 1325785 Model CE0540DR, BARD CATHETER, lot numbers 1284054, 1284951, 1328361 Model CE0580DR, BARD CATHETER, lot numbers 1255414, 1263517, 1276230, 1283948, 1286831, 1289126, 1295732, 1301799, 1308735, 1317737, 1318091, 1325790, 1335172 Model CE0680DR, BARD CATHETER, lot numbers 1250869, 1260041, 1268157, 1276234, 1283950, 1284954, 1289024, 1295730, 1303736, 1308740, 1314577, 1318092, 1324358

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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

2 other products · FDA event 85057

This product is part of a recall event; the main page for the event is Python Embolectomy Catheters, Sterile EO, CE recalled.

Reported	Class	Recall	Company	Reason	Where
13 May 2020	CLASS I	Python Embolectomy Catheters, Sterile EO, CE recalled	Applied Medical Resources	Other	Nationwide
13 May 2020	CLASS I	Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc recalled	Applied Medical Resources	Other	Nationwide

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