MARLBOROUGH, Mass.,
April 8, 2016 /PRNewswire/
-- Boston Scientific (NYSE: BSX) has initiated a global,
voluntary recall of all models of its Fetch™ 2 Aspiration Catheter,
a thrombectomy catheter used during procedures to remove small
blood clots from coronary arteries. The Fetch 2 catheters were
recalled on March 22, 2016, due to
complaints of shaft breakage. The U.S. Food and Drug Administration
(FDA) classified the action as a Class 1 recall. This recall
designation means that the use of the device exposes the patient to
a reasonable chance of a serious adverse health consequence or
death.
There have been no reports of patient injury or death, and there
is no risk to patients who previously underwent a thrombectomy
procedure with the Fetch 2 catheter. All reports of shaft breakage
happened during the procedure, and the broken section was either
removed while still partially attached to the catheter shaft or
retrieved with a snare, without further patient complications.
While unreported, the most severe potential outcome of this
breakage is embolism of device fragments, which could lead to
obstruction of blood flow or additional intervention to remove a
device fragment surgically.
As part of the recall, all affected healthcare facilities were
advised to discontinue use of all Fetch 2 catheters immediately and
return unused product to Boston Scientific. Because Boston
Scientific acquired the Fetch 2 catheter product line from Bayer
Medical Care Inc., all recalled inventory is packaged and labeled
as Bayer product. This device was manufactured between June 11, 2014 and February
19, 2016. There are currently 21,155 devices on the market
subject to this recall.
Fetch 2 Catheter
UPNs
|
FETCH2 US
109400-001
|
FETCH2 OUS
109400-002
|
FETCH2
Canada
109400-003
|
FETCH2
Japan
109400-004
|
FETCH2 EU
109400-005
|
Physicians and healthcare facilities can direct questions to
their Boston Scientific representative or, call 1-800-811-3211.
Adverse reactions or quality problems experienced with the use of
this product may be reported to the FDA MedWatch Adverse Event
Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online:
www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request
a reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178
or
- Health care professionals and consumers may report serious
adverse events or product quality problems with the use of this
product to Boston Scientific by calling 1-800-811-3211 and to the
FDA's MedWatch Adverse Event Reporting program either online, by
regular mail, fax or phone.
CONTACT:
Trish
Backes
Corporate Communications
Boston Scientific Corporation
+1 (651) 582-5887
Trish.Backes@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
+1 (508) 683-5565
investor_relations@bsci.com
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SOURCE Boston Scientific