The Recall Desk
HighFDA (Devices)·Z-1846-2020·Announced 2020-05-13

Applied Medical Recalls Python Embolectomy Catheters Due to Tip Separation

Applied Medical Resources Corp is recalling Python Embolectomy Catheters because the tips may separate during use, posing a risk of unintended dislodgement in patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (tip separation) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Applied Medical Resources Corp is recalling 28,799 Python Embolectomy Catheters, Sterile EO, CE. The recall covers specific models and lot numbers distributed nationwide in the United States and in several countries worldwide, including Australia, Canada, and the United Kingdom.

The recall was initiated after the firm received reports of tip separation during the usage of the catheters. This defect may expose patients to the unintended dislodgement of the tip from the body of the catheter.

Healthcare facilities and distributors should stop using the affected catheters and contact Applied Medical Resources Corp for further instructions on the recall.

The recalled product

Product
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
Manufacturer
Applied Medical Resources Corp
Category
Medical Device — Catheters
Hazard
Affected units
28,799

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model A4E01
  • PYTHON 5MM-40CM
  • lot numbers 1259463
  • 1268371
  • 1274343
  • 1281314
  • 1288397
  • 1291497
  • 1302766
  • 1305919
  • 1312958
  • 1317578
  • 1319209
  • 1324383
  • 1326383
  • 1333050
  • 1338309
  • 1339544. Model A4E02
  • PYTHON 5MM-80CM
  • lot numbers 1257416

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Applied Medical Resources Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Applied Medical Resources Corp

See all →

Same hazard · tip separation

See all →