Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

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: tip-separation
device-failure
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 →

Same manufacturer · Applied Medical Resources Corp

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Same hazard · tip separation