CLASS I Device recall · Reported 13 May 2020 · FDA Enforcement Report
Python Embolectomy Catheters, Sterile EO, CE recalled
Applied Medical Resources is recalling Python Embolectomy Catheters, Sterile EO, CE, 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
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-1846-2020
- 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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
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
Questions about this recall
Is Python Embolectomy Catheters, Sterile EO, CE recalled?
Yes. Applied Medical Resources recalled Python Embolectomy Catheters, Sterile EO, CE on 24 Oct 2019. The recall is Class I and its status is Terminated. Recall number Z-1846-2020.
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 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, 1268372, 1281315, 1283401, 1293028, 1294897, 1303013, 1305920, 1317579, 1319807, 1324384, 1331435, 1332003, 1338732, 1339490 Model A4E03, PYTHON 9MM-40CM, lot numbers 1256874,1263093,1269005,1276315,1281787,1287079,1298430,1303017, 1308139, 1319211, 1330447, 1331896, 1333407, 1337644, 1341362 (note: lot numbers edited for correctness 4/23/2021) Model A4E04, PYTHON 9MM-80CM, lot numbers 1255539, 1262756, 1269004, 1276316, 1281786, 1288847, 1293169, 1299257, 1303808, 1312595, 1319212, 1321387, 1325381, 1331884, 1332592, 1337686, 1339491 Model A4E05, PYTHON 11MM-40CM, lot numbers 1263092, 1268170, 1273184, 1278603, 1283650, 1288347, 1292823, 1296020, 1299013, 1305922, 1310451, 1318835, 1320036, 1323535, 1325777, 1330446, 1331328, 1337641, 1339492 Model A4E06, PYTHON 11MM-80CM, lot numbers 1261855, 1268451, 1276317, 1284924, 1290454, 1298079, 1305921, 1310623, 1320183, 1323280, 1330449, 1332579, 1337652, 1339493 Model A4E08, PYTHON 13MM-80CM, lot numbers 1252636, 1259464, 1263484, 1265630, 1266989, 1267854, 1268688, 1276314, 1281784, 1283399, 1287076, 1290936, 1294898, 1303211, 1306288, 1308127, 1312957, 1315919, 1317577, 1319637, 1320236, 1324382, 1332433, 1335657, 1339494 Model A4E09, PYTHON 14MM-80CM, lot numbers 1260019, 1273374, 1281783, 1283770, 1295466, 1299012, 1305368, 1317203, 1317876, 1319210, 1324390, 1330448, 1332593, 1337653, 1339495
Where was it sold?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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