Food, drugs, devices › Boston Scientific Corporation
Device recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
FDA enforcement event 84150 is a device recall by Boston Scientific Corporation of Marlborough, MA, initiated 21 Oct 2019 and classified Class II, with 13 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 20 Dec 2023. Initiation: voluntary: firm initiated. Boston Scientific Corporation has 162 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Boston Scientific Corporation, Marlborough, MA.
Reason for recall
"Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life"
Distribution
"Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0548-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610 | 109 units | Class II | Terminated | 4 Dec 2019 |
| Z-0549-2020 | Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620 | 66 units | Class II | Terminated | 4 Dec 2019 |
| Z-0550-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630 | 542 units | Class II | Terminated | 4 Dec 2019 |
| Z-0551-2020 | Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 | 54 units | Class II | Terminated | 4 Dec 2019 |
| Z-0552-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650 | 940 units | Class II | Terminated | 4 Dec 2019 |
| Z-0553-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660 | 97 units | Class II | Terminated | 4 Dec 2019 |
| Z-0554-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670 | 651 units | Class II | Terminated | 4 Dec 2019 |
| Z-0555-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680 | 222 units | Class II | Terminated | 4 Dec 2019 |
| Z-0556-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690 | 139 units | Class II | Terminated | 4 Dec 2019 |
| Z-0557-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700 | 271 units | Class II | Terminated | 4 Dec 2019 |
| Z-0558-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710 | 66 units | Class II | Terminated | 4 Dec 2019 |
| Z-0559-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206 | 179 units | Class II | Terminated | 4 Dec 2019 |
| Z-0560-2020 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730 | 35 units | Class II | Terminated | 4 Dec 2019 |
Context
Other enforcement events for Boston Scientific Corporation
All 162 events for Boston Scientific Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Dec 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.