Inspections, Compliance, Enforcement, and Criminal Investigations
Notification: Non-Sterile Boston Scientific Devices Stolen
Endoscopy and Urology / Women’s Health Devices
URGENT: Risk of Infection
FDA posts press releases and other notices from firms as a service to consumers, the media, and other interested parties.
Date Posted: May 3, 2011
Dear Risk/Materials Manager:
Boston Scientific Corporation is alerting you about a stolen shipment of Endoscopy and Urology / Women’s Health medical devices. These devices were stolen while en route to our sterilization facility sometime between April 8, 2011 and April 11, 2011.
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.
Required Actions
- Check your inventory for affected product
- Segregate
- Monitor all incoming shipments for affected product
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.
Only the specific UPNs and Batches identified in the table below are affected. If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, please do not use the devices and contact Boston Scientific at 866-868-4004.
Please visit our website at BostonScientific.com for information on device labeling, device photos and other additional information concerning this issue.
If you are a distributor, please note that this notification should be forwarded to your customers.
Below is the list of affected devices, including Device Description, Material/UPN/Catalog Number and Lot/Batch Number.
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 |
Device Name | Device Description | Material/UPN/ Catalog Number | Lot/Batch Number |
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. | M00522511 | 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™; 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. | M00522611 | ML000017C2 |
Resolution Clip™; 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. | M00522611 | ML000018C2 |
Resolution Clip™; 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. | 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 |
Device Name | Device Description | Material/UPN/ Catalog Number | Lot/Batch Number |
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 |
Boston Scientific Corporation is working with the U.S. Food and Drug Administration and law enforcement officials to recover this stolen shipment.
Your vigilance related to any suspicious transactions relating to the devices listed above is greatly appreciated. For example unusually low pricing may be an indication that the product has been stolen.
Anyone who has information regarding this incident or has received suspicious or unsolicited offers for the devices identified above, after the date of the theft, is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or by visiting the OCI Web Site at (http://www.fda.gov/OCI).
If you have questions or concerns regarding the affected devices, contact Boston Scientific at 866-868-4004.
We regret any inconvenience that this situation may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. We are committed to continuing to offer products that meet the highest quality standards that you expect from Boston Scientific.
Sincerely,
Cindy Finney
Field Action Team Lead
508-683-4678(p)
508-683-5578(f)
