Health product recall

AMS 700 MS (Momentary Squeeze) Pump (2020-09-24)

Starting date:
September 24, 2020
Posting date:
October 9, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74087

Last updated:
2020-10-09

Affected Products

A. LGX PRECONNECT MS 18CM PS SKU

B. PUMP MS IZ

C. LGX PRECONNECT MS 15CM PS IZ

D. LGX PRECONNECT MS 12CM IP IZ

E. CX PRECONNECT MS 18CM PS IZ

F. CX PRECONNECT MS 15CM IP IZ

G. CXR PRECONNECT MS 14CM PS IZ

H. CXR PRECONNECT MS 16CM IP IZ

Reason

Product removal of unused inventory of the AMS 700 MS (Momentary Squeeze) Pump following an increase in complaints related to the initial activation of the device. An "initial activation" complaint refers to a problem encountered during the initial activation of the device, typically within the first 2 months after an AMS 700 implant procedure, in which the patient and/or physician is unable or has difficulty activating the pump in order to achieve cylinder inflation, even after exhaustive troubleshooting and patient training.

Affected products

A. LGX PRECONNECT MS 18CM PS SKU

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404301
72404302
72404303

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES

B. PUMP MS IZ

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404209

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES

C. LGX PRECONNECT MS 15CM PS IZ

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404250
72404251
72404252
72404253

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES

D. LGX PRECONNECT MS 12CM IP IZ

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404255
72404256
72404257
72404258

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES

E. CX PRECONNECT MS 18CM PS IZ

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404230
72404231
72404232
72404233

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES

F. CX PRECONNECT MS 15CM IP IZ

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404235
72404236
72404237
72404238

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES

G. CXR PRECONNECT MS 14CM PS IZ

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404261
72404262
72404263

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES

H. CXR PRECONNECT MS 16CM IP IZ

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72404266
72404267
72404268

Companies
Manufacturer

American Medical Systems Inc

10700 Bren Road West

Minnetonka

55343

UNITED STATES