Reported Dec 30, 2015 · Terminated
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4;…
Boston Scientific Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corp · 150 Baytech Dr · San Jose, CA · 95134-2302
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
| — | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40 |
PM4500N4 | — |
| — | Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation. |
- Lot codes and dates
- Material NumberM004PM4500N40
- Catalog numberPM4500N4
- Lot numbers
16309584166159761662375416623755167224341673692716739588167432711687212416999075171181111715741817201805172220511722205217370483173765731737657417436562174365631743656517451802174789501749914517499152175905031761178517625992177683061779142017925492179254931801220818161715
- Expiration Date Range8/15/2016 to 7/2/2018
- Amount recalled
- 1556 total - all models
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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