CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report
Scoop Tip Cholangiogram Catheter with Introducer (eIFU) recalled
LeMaitre Vascular is recalling Scoop Tip Cholangiogram Catheter with Introducer (eIFU), distributed nationwide in the US. The recall was initiated on 7 Feb 2017 and the FDA has classified it as Class II.
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-1450-2017
- FDA event ID
- 76476
- Recalling firm
- LeMaitre Vascular, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2017
- FDA classified
- 13 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Feb 2017 | Recall initiated by company | |
| 13 Mar 2017 | Classified by FDA | +34 days |
| 22 Mar 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
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
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Where it was distributed
Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Questions about this recall
Why was it recalled?
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Which lots are affected?
Lot Number/Exp. Date: RST2391 2018-09 RST2394 2018-09 RST2395 2018-09 RST2406 2018-12 RST2407 2018-12 RST2414 2019-02 RST2415 2019-02 RST2421 2019-03 RST2422 2019-03 RST2429 2019-04 RST2430 2019-04 RST2435 2019-05 RST2445 2019-07 RST2446 2019-07 RST2451 2019-08
Where was it sold?
Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
11 other products · FDA event 76476This product is part of a recall event; the main page for the event is Reddick Scoop Tip Cholangiogram Stiffer Catheter recalled.
More recalls from LeMaitre Vascular
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Artegraft Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | Nationwide |
| Device | CLASS II | Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | AR |
| Device | CLASS II | Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Labeling Errors | NJ |
| Device | CLASS II | Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular | LeMaitre Vascular | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |