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