Boston Scientific (NYSE:BSX) is warning customers about a possible risk of infection from a stolen shipment of unsterilized endoscopy, urology and women’s health instruments.
"These devices were stolen while en route to our sterilization facility sometime between April 8, 2011 and April 11, 2011," according to a May 3 notice posted on the FDA’s website.
"The labels on these devices state that they are ‘Sterile;’ however, they were stolen prior to being sterilized and are non-sterile. Use of these non-sterile devices may lead to infection."
The Natick, Mass.-based medical device maker said customers should ascertain whether their inventory contains the affected products (see below), pull any found from circulation and monitor their incoming stock for affected products.
"It is recommended that health care professionals monitor and treat patients for adverse events, such as post-operative infection, if they suspect or know that the below stolen non-sterile devices have been used," according to the FDA warning page.
Boston Scientific said it’s working with the FDA and law enforcement to recover the stolen shipment.
The company asked customers for "vigilance related to any suspicious transactions relating to the devices listed above," cautioning them to keep an eye out for unusually low pricing and ecouraging anyone who receives " suspicious or unsolicited offers for the devices" to contact the FDA’s Office of Criminal Investigations.
Here’s a list of the affected devices, catalog numbers and lot or batch numbers:
Device Name | Device Description | Material/UPN/ Catalog Number | Lot/Batch Number | Resolution™ II; 155cm; Box 20 | Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations. | M00522502 | ML00000042 |
Resolution™ II; 235cm Box 10 | Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations. | ML00000043 | |
Resolution™ II; 235cm Box 20 | Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations. | M00522512 | ML00000040 |
Resolution Clip™; 235cm (single unit) | Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations. | M00522610 | ML000019C2 |
Resolution Clip™; Box 10 | Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations. | M00522611 | ML000017C2 |
Resolution Clip™; Box 10 | Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations. | M00522611 | ML000018C2 |
Resolution Clip™; Box 20 | Clipping device used for placement in the gastro-intestinal (GI) tract for hemostasis, endoscopic marking, anchoring jejunal feeding tubes or as a supplementary method for closure of GI tract luminal perforations. | M00522612 | ML000020C2 |
Pinnacle™ Pelvic Floor Repair Kit | Pelvic Floor Repair Kit: Kits used for Pelvic Floor Repair of Pelvic Organ Prolapse | M0068317050 | ML00000034 |
Flexiva™ 365 High Power Single-Use Laser Fiber; Box 5 | Fiber optic laser energy delivery devices | M0068403921 | ML00000046 |
Flexiva™ 550 High Power Single-Use Laser Fiber | Fiber optic laser energy delivery devices | M0068403930 | ML00000060 |
Flexiva™ 1000 High Power Single-Use Laser Fiber | Fiber optic laser energy delivery devices | M0068403940 | ML00000048 |
AccuMax ™ 365 Single-Use Holmium Laser Fiber | Fiber optic laser energy delivery devices | M0068404020 | ML00000061 |
Advantage™ System (single unit) | Implantable mesh slings used for stress urinary incontinence | M0068502000 | ML00000035 |
Advantage™ System; Box 5 | Implantable mesh slings used for stress urinary incontinence | M006850200051 | ML00000036 |
Advantage Fit™ System; Box 5 | Implantable mesh slings used for stress urinary incontinence | M0068502111 | ML00000038 |